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Pharmaceutical patent litigation ensues when a pharmaceutical company “bends” the patent laws. A patent expires after 20 years, but a company could apply to extend the patent. If a patent is extended, there is a possibility that a monopoly could be formed. If a monopoly on a certain drug is formed, health care costs rise, and it might be difficult for a patient to obtain a much-needed drug.
During patent litigation, discovery is always required. All documents, electronic and hard copy, must be provided to the opposing counsel. Certain documents are exempt from discovery. These documents fall under certain confidentiality laws and include certain correspondence between an attorney and the attorney's client.
Discovery requests come in different forms: requests for production, interrogatories, depositions, and requests for admissions. Documents may be requested in any of these formats. Prior to providing documents, an attorney must review the documents being sent out to ensure that no confidential documents are being produced.
The document review process is time consuming, so many firms retain temporary attorneys experienced in the pharmaceutical field to review documents prior to production.
Pharmaceutical litigation ensues for different reasons—a patient might have been injured by a drug or a piece of medical equipment, or a company might have violated monopoly laws by “bending” the patent laws. Regardless of the type of pharmaceutical litigation, the plaintiff and the defendant must produce discovery. Discovery requests come in different forms: requests for production, interrogatories, depositions, and requests for admissions.
Before discovery is produced to the opposing counsel, documents must be reviewed for content. Document review attorneys check documents for confidential and/or privileged information. Documents are electronic (email, scanned, etc.) or in hard copy form. Certain documents fall under confidentiality laws, including correspondence between an attorney and the attorney's client. Documents that fall under attorney-client privilege are not discoverable, and if produced, can lead to requests for other confidential documents.
Document review is time consuming, and a firm often retains temporary attorneys provided by legal staffing agencies to help review the copious documents requested by the opposing counsel.
Pharmaceutical companies patent new drugs they invent, but there are at least two ways that patents negatively affect the practice of medicine and patient care. Since patents only last 20 years before they are available to other companies, patent holders often use legal loopholes to extend the exclusivity of their drugs. The inventors of the drugs ask for and receive patents on drugs that bend statutory patenting requirements. Both actions might cause a monopoly on drugs, which in turn causes the cost of health care to rise and limits patient options.
When patent litigation ensues, documents regarding the patent and other documents relating to the drug or medical device must be provided during the discovery phase. Certain documents fall under confidentiality rules and are not discoverable. These documents must be separated from the discoverable documents prior to responding to discovery requests, interrogatories and requests for admissions.
Experienced, temporary pharmaceutical document review attorneys that are provided by legal staffing companies help firms by reviewing the documents prior to discovery. This allows the lead attorneys to pay more attention to other aspects of the case during litigation preparation.
Pharmaceutical drug litigation ensues when a person is injured by a drug, including drug side effects, drug injuries, errors in prescriptions, whether by a pharmacist or another medical professional, and medical device malfunctions, among other pharmaceutical matters. The personal injury pharmaceutical lawyers also represent family members of a person that has died a wrongful death because of pharmaceutical errors.
Some medications and medical devices have been recalled due to health risks and certain side effects and malfunctions of drugs and medical devices. Several drugs, including Celebrex, Vioxx, Bextra, Ephedrine, Paxil, and Crestor have been recalled.
During litigation, the defendant and the plaintiff must provide documents to one another. Documents include medical records, drug records (FDA records and other drug records), financial statements, and other correspondence and court papers. Some of these documents, especially correspondence between the attorney and the attorney's client, are deemed confidential. These documents should not be provided during the discovery phase of litigation.
Legal staffing agencies provide legal process outsourcing jobs for attorneys that are experienced in the pharmaceutical field. Many firms in the pharmaceutical field need experienced document review attorneys. Document review attorneys review documents, whether electronic or hard copies, for confidentiality issues.
The biggest confidentiality issue at hand is attorney-client privilege. Emails are exchanged between attorneys on the case and between an attorney and the attorney's client. The emails and other correspondence between the attorney and the attorney's client is usually confidential in nature and is not subject to disclosure.
If an email or other attorney-client correspondence is provided in discovery to the opposing counsel(s), it might open the way for additional attorney-client documents to be requested in the discovery process. Document review attorneys ensure that no documents that fall under attorney-client privilege are inadvertently disclosed.
Pharmaceutical cases are often extensive because of the amount of documentation involved. Insurance companies (represented by their own attorneys) for the plaintiffs and defendants are also involved, increasing the amount of “paper” that goes between attorneys.
Litigation can be complicated in a case involving so many people. A legal staffing agency provides litigation support services for attorneys involved in pharmaceutical cases. Support services include but are not limited to additional staff (attorneys, legal assistants, and paralegals), document retrieval, document review services and document management services.
Documents are digitized for a particular case and indexed by keywords. Keywords are chosen based on subject matter and names within each document. Documents include email, PDF files, Excel, Word and PowerPoint files, and image files. Once documents are digitized, they are easier to find, which saves a firm time, money and storage costs. Documents needed for a particular discovery request or for other reasons could be searched for via keyword. Litigation support personnel is also available to create extensive document notebooks for discovery, settlement negotiations, hearing and trial.
|Jennifer Mathes, Ph.D.|